Development and characterization of antibody reagents to assess anti-PEG IgG antibodies in clinical samples. (August 2015)

• Record Type: Journal Article
• Authors: Krishna, Murli; Palme, Holly; Duo, Jia; Lin, Zheng; Corbett, Martin; Dodge, Robert; Piccoli, Steven; Myler, Heather; Pillutla, Renuka; Desilva, Binodh
• Is Part Of: Bioanalysis. Volume 7:Number 15(2015)
• Page Start: 1869
• Page End: 1883
• Publication Date: 2015-08
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.15.112
• Languages: English
• ISSNs: 1757-6180

Abstract

Background: Polyethylene glycol (PEG) is a polymer that can be conjugated with therapeutic proteins. Monitoring anti-PEG antibodies in human subjects may be required as part of immunogenicity assessment. The lack of well-characterized anti-PEG reagents have limited our understanding of anti-PEG humoral response.Results: Antibodies reactive to PEG were engineered with a human IgG1 Fc. Surface plasmon resonance and plate-based methods demonstrated that their binding was dependent on molecular weight (MW) of PEG. Specificity experiments using chemical analogs identified their specificity.Conclusion: Affinity, specificity and MW of PEG are critical characteristics that impact interactions of anti-PEG antibodies with PEG. These attributes especially MW of PEG and the assay formats may impact the ability to detect anti-PEG antibodies.